Study identification

EU PAS number

EUPAS7301

Study ID

14343

Official title and acronym

Observational influenza vaccine active surveillance study: A Phase IV Prospective Multi-Centre Cohort Study to Evaluate the Reactogenicity of bioCSL’s influenza virus vaccine (CSLCT-SAF-14-05)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

To characterise the reactogenicity (local, systemic and allergic reactions) within seven days after each influenza vaccination with bioCSL’s influenza virus vaccine in participants routinely indicated for influenza vaccination in specified age groups.To assess the frequency and severity of medically attended adverse events with initial symptom onset within seven days after each influenza vaccination with bioCSL’s influenza virus vaccine.

Study status

Finalised
Research institutions and networks

Institutions

Knowle House Surgery PL5 3JB Plymouth, UK, The Rame Group Practice PL11 2JW Torpoint, UK, The Honiton Surgery Ward Practice EX14 2NY Honiton, Leicester Terrace Healthcare Centre NN2 6AL Northampton, Bradford on Avon Health Centre BA15 1DQ Bradford-on-Avon, Axbridge and Wedmore Medical Practice BS26 2BJ Axbridge, Harbinson House Surgery TS21 3BN Sedgefield, The Haven Surgery DH7 OBD Burnhope, University of Nottingham Health Service NG7 2QW Nottingham, East Quay Medical Centre TA6 4GP Bridgwater

Networks

Contact details

James Larcombe

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

bioCSL GmbH
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 2 (specific obligation of marketing authorisation)